Actively Recruiting
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Led by Henan Cancer Hospital · Updated on 2025-06-25
104
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients
CONDITIONS
Official Title
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Newly diagnosed breast cancer with no distant metastasis
- Require adjuvant radiotherapy
- Scheduled for nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant reconstruction or two-stage expander/implant reconstruction
- Mesh use in reconstruction surgery allowed
- Severe breast ptosis allowed
- Lipofilling on affected breast and symmetrization on contralateral breast permitted during study
- ECOG performance status 0-1
- Receiving neoadjuvant chemotherapy allowed
- Bilateral breast reconstruction permitted
- No smoking history or smoking cessation at least 4 weeks before enrollment
- Confirmed ability to comply with protocol
- Participation in other non-interfering trials allowed
- Voluntary participation with informed consent
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- No prior radiotherapy after mastectomy
- History of radiation therapy to the same chest wall or axilla
- Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use
- Inflammatory breast cancer (cT4d)
- Autologous or delayed breast reconstruction
- Severe cardiopulmonary, liver, or kidney diseases contraindicating surgery or radiotherapy (ASA class ≥III)
- Psychiatric disorders preventing independent BREAST-Q completion
- Pregnancy or breastfeeding
- History of not following study protocol
- Life-limiting conditions interfering with treatment or investigator-determined ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan cacer hospital
Henan, Henan, China, 450008
Actively Recruiting
Research Team
X
xiuchun Chen
CONTACT
M
minhao Lv
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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